Children’s Hospital Los Angeles Performs World’s First Implant of a Novel Stent for Babies

The objective of the clinical investigation is to access device performance and the initial clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.

 Prospective, multi-center, non-randomized treatment study with one arm.

Minima Stent deployment success, patient stenosis relief, safety, and patient freedom from explantation. Re-dilation and more will be monitored as a secondary endpoint.

10 participants with native or recurrent common vascular stenosis as a part of the Early Feasibility Study in up to 5 US sites.